Evaluation of Thermal-Aided Muscle Stimulation

Niveus Medical

Status: Unknown

Conditions: Weakness; Atrophy

Treatments: Device: Body Temperature Stimulation; Device: Thermal-aided muscle stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911312

CLP3.00

Details and patient eligibility

About

An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject does not meet any exclusion criteria

Exclusion criteria

• Age < 18 years
• Subject is pregnant
• Subject has an implanted pacemaker/defibrillator
• Subject diagnosed with epilepsy
• Subject has implanted metallic femoral rods
• Subject is chair- or bed-bound
• Subject has neuromuscular disease or abnormalities
• Subject BMI > 45
• Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Device: Thermal-aided muscle stimulation

Body Temperature Control

Active Comparator group

Description:

Stimulation performed with body temperature control

Treatment:

Device: Body Temperature Stimulation